What is MDDS?

A new classification regulation effective February 2011

21 CFR 880.6310 - Medical device data system

Initial MDDS registration was required by May 16th, 2011

MDDS will be actively enforced beginning April 18th, 2012 through on-site FDA inspections

Medical device data is electronic data that originates from a medical device

MDDS reclassifies data systems that electronically:

Transfer, store, convert or display medical device data

Includes software, electronic or electrical hardware (including wireless), modems, interfaces and communication protocols

MDDS does not include devices intended to be used in connection with active patient monitoring

MDDS Facts

Medical device data always originates from a medical device

Labeling can partially define the regulated system – i.e., what uses are claimed

An MDDS may be a single component (storage, display, communication component), or any combination of these components

An MDDS can initiate and control communication

Data transmitted through an MDDS can control a device, but the control command must have originated from another device

An MDDS can facilitate communication, but may not alter the data in transit

Potential MDDS or MDDS+ Systems

Bedside data displays

Customization to commercially purchased systems

Work flow “wrappers”

Clinical decision support systems

IV Pump, Infusion, Dosing and Rx systems

Nutrition and Wellness systems

Ventilator management systems

Anesthesia systems

Sterilization and asset workflow systems

Enroute (to medical facility) support systems

Flight for life, ambulance

Fetal monitor displays

Echo cardiogram displays

Medical data merged from numerous systems

Custom interfaces for medical devices and clinical information systems

Smart phone, PDA, iPad apps (Mobile Medical Apps)

QMR - MDDS Solution Steps

1. Conduct a Product Classification Assessment

Are your systems MDDS, MDDS+, not MDDS?

2. Register and List MDDS devices

3. Conduct Quality System Gap Assessment

Depending on the existence of MDDS or higher

Risk based

4. Write a Quality System (QS) Implementation Plan

Identify staff, establish budget and timeline

Prepare to meet or beat April 18th, 2012

5. Execute the QS Implementation Plan

Project team should minimally include: Project Manager / Owner, QA, Regulatory/ Compliance, Clinical, Risk Management, Information Technology, System Users

Regulatory professionals with expertise in:

Medical Device Data Systems Assessments (currently 7 projects)

Medical device and GxP information systems validation (20+ projects)

Device classification and reclassification

Implementing Quality Systems, labeling, medical device reporting and other applicable FDA requirements

Considerable experience with mobile, wireless, wellness home health and tele-health devices, including EMC/RF issues

Regulatory responsibility for Information Technology departments (20+ years)

Vendor management, including vendor selection for outsourcing critical corporate compliance and decision support systems (20+ years)

AAMI/FDA MDDS Working Group committee member

Excellent relationships with key FDA personnel

Training for GxP, QSR, MDR, recalls, software validation, regulatory awareness, risk management

510(k) submissions (35+)

Experience in VP, “C” level and Director roles in QA, IT, Regulatory, Compliance and Internal Audit

Technical resource team with expertise in all applicable disciplines